Combined decontamination with charcoal and PEG in severe poisoning

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized trial, adults admitted to the ICU with severe poisoning from cardiotropic or psychotropic drugs will receive either a combination of activated charcoal and polyethylene glycol or standard charcoal-based treatment. The primary goal is to see if the combination lowers the plasma concentration of the ingested toxin at 24 hours after randomization. The study uses a 1:1 allocation over 24 months and focuses on patients who require mechanical ventilation. Safety monitoring and predefined endpoints will compare toxicant reduction between groups, with secondary analyses exploring additional pharmacokinetic outcomes and clinical correlations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patient aged ≥18, intoxicated and hospitalised in intensive care AND

* Main drug toxicant of functional type (any psychotropic or cardiotropic), adsorbable by activated charcoal And
* Main toxicant identified by the history taken by a healthcare professional on the ward or during care prior to the ward And
* Main toxicant identified within 3 hours of admission if the patient is already intubated on admission, or within 3 hours of intubation if the patient is intubated on the ward AND
* Patient intubated for effects attributed to the toxic agent (neuro-respiratory or haemodynamic failure) AND
* Patient with nasogastric tube or planned nasogastric tube and no contraindications AND
* Main toxicant whose assay can be performed by the toxicology laboratory at Lariboisière Hospital AND Inclusion according to the emergency clause
* Written informed consent from a parent/relative/trusted person. In the absence of a parent/relative/trusted person, the patient may be included under the emergency procedure and consent will be obtained as soon as possible.

Exclusion Criteria:

* No social security affiliation
* Non-intubated patient
* Contraindication to the administration of one of the study products (e.g. suspected digestive perforation, intestinal obstruction, inflammatory bowel disease, etc.)
* Inability to insert a nasogastric tube
* Repeated vomiting prior to inclusion, making digestive decontamination impossible
* Digestive haemorrhage in progress or during the previous month
* Ingestion of metals (e.g. iron, caesium, thallium, lead, copper, cadmium)
* Isolated or predominant alcohol poisoning (e.g. ethyl alcohol, ethylene glycol, methanol)
* Intoxication by gas (e.g. carbon monoxide or fire fumes)
* Intoxication by a caustic product (acids or bases)
* Main toxicant ingested under liquid form
* Intoxication by a toxic lesion
* Intoxication by a non-medicated product (e.g. party drugs)
* Intubation for causes not attributed to the ingested toxic substance (e.g. massive inhalation pneumonia)
* In-body carrier of drug pellets
* Pregnant or breast-feeding patients
* Patients being treated for dementia
* Patient under guardianship or curatorship
* Patients under legal protection
* Patients deprived of their liberty

Where it's running

• Sebastian Voicu
  Paris, France Recruiting

Study contacts

• Principal investigator: Voicu Sebastian, MD — Aphp(assistance Publique Des Hopitaux de Paris)
• Study coordinator: Voicu Sebastian, MD
• Email: sebastian.voicu@aphp.fr
• Phone: 0149958442

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.